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Biosimilars—why terminology matters


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  1. Regulation (EC) 726/2004 of the European Parliament and of the Council. Official J. EU L136/1–L136/33 (2004).

  2. Committee for Medicinal Products for Human Use. Biosimilar Guidelines (accessed 20 July 2011);

  3. European Commission. Directive 2001/83/EC Art. 10(4) and Part II of the Annex I of Directive 2001/83/EC, as amended. EudraLex, Volume 1, Pharmaceutical legislation medicinal products for human use (accessed 20 July 2011);

  4. European Medicines Agency. Guideline on Comparability of Biotechnology-Derived Medicinal Products After a Change in the Manufacturing Process: Non-Clinical and Clinical Issues EMEA/CHMP/BMWP/101695/2006 (EMA, London, 19 July 2007; accessed 20 July 2011)

  5. Chirino, A.J. & Mire-Sluis, A. Nat. Biotechnol. 22, 1383–1391 (2004).

    Article  CAS  PubMed  Google Scholar 

  6. Schellekens, H. NDT Plus 2 (suppl. 1), i27–i36 (2009).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Brockmeyer, C. & Seidl, A. EJHPPract. 15, 38–44 (2009).

    Google Scholar 

  8. European Medicines Agency. EPARs for authorised medicinal products for human use (accessed 20 July 2011);

  9. Combe, C., Tredree, R.L. & Schellekens, H. Pharmacotherapy 25, 954–962 (2005).

    Article  CAS  PubMed  Google Scholar 

  10. Schmidt, C.A., Ramos, A.S., da Silva, J.E.P., Fronza, M. & Dalmora, S.L. Arq. Bras. Endocrinol. Metabol. 47, 183–189 (2003).

    Article  Google Scholar 

  11. Keithi-Reddy, S.R., Kandasamy, S. & Singh, A.K. Kidney Int. 74, 1617–1622 (2008).

    Article  PubMed  Google Scholar 

  12. Gray, E. & Mulloy, B. J. Thromb. Haemost. 7, 1218–1221 (2009).

    Article  CAS  PubMed  Google Scholar 

  13. Wenzel, R.G. Am. J. Health Syst. Pharm. 65 (suppl. 6), S9–S15 (2008).

    Article  PubMed  Google Scholar 

  14. World Health Organization. General information on counterfeit medicines (accessed 20 July 2011)

  15. Fotiou, F., Aravind, S., Wang, P.P. & Nerapusee, O. Clin. Ther. 31, 336–346 (2009).

    Article  CAS  PubMed  Google Scholar 

  16. Anonymous. Aids Alert 18, 79–80 (2003).

  17. World Health Organization. Expert Committee on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (WHO, Geneva, 2009; accessed 20 July 2011)

  18. Federal Drug Administration. Follow-on protein products: regulatory and scientific issues related to developing (accessed 31 May 2011)

  19. Patient Protection and Affordable Care Act, as amended by the 111th Congress, H.R. 3590 (accessed 20 July 2011).

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The authors wish to thank colleagues from the Biologicals Working Party (BWP), in particular its Chairman, J.-H. Trouvin, for valuable comments on the manuscript.

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Correspondence to Martina Weise.

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Weise, M., Bielsky, MC., De Smet, K. et al. Biosimilars—why terminology matters. Nat Biotechnol 29, 690–693 (2011).

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